Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of noya sirolimus-eluting stent to treat coronary artery disease

Conditions: Coronary Artery Disease

Summary: a prospective, multicenter study is preformed to evaluate the safety and efficacy of noya cocr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.

a prospective, multicenter study is preformed to evaluate the safety and efficacy of noya cocr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 180, 365 days,2 years,3 years,4 years and 5 years. target lesion failure (tlf) found in following-up period as key indicators to evaluate the safety of stents. the arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent data management center(dmc) and radiography core laboratory.

Eligibility criteria:
inclusion criteria: * the patient must be ≥18 of age; male or non-pregnant female. * diagnosis of coronary artery disease. * at least one target lesion with a diameter stenosis ≥70% (visual estimate) * acceptable candidate for cabg; * the patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written notice of informed consent, appropriate ethics committee(ec); and the patient is willing to comply with specified follow-up evaluations. exclusion criteria: * patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (nyha ≥ ⅲ level), or left ventricular ejection fraction ≤ 30%. * patient has undergone previous stenting anywhere within the previous 1 year. patient has a preoperative renal dysfunction: serum creatinine\> 2.0mg/dl (176.82umol / l). * patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year; * patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (pla) polymer, and/or contrast sensitivity that cannot be adequately premedicated; * patient is allergic to contrast agent sirolimus. * patient has a limited life expectancy is less than 12 months. * currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up. * patient has poor compliance with the judgment of the investigator and can not complete the study as required. * patient who had heart transplant.
feasibility and effectiveness of a coordinated healthcare circuit dedicated to patients with handicap

Conditions: Disabilities Physical; Disabilities Mental

Summary: france currently has more than 10 million disabled people, including 3 millions who could be better treated. in fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments. the infra health circuit has been set up at the "groupe hospitalier mutualiste de grenoble" since june 2018 according to the guidelines published by the french high authority for health (has) on improving professional practices "reception, support and organization of care in health establishments for people in situation of handicap "of july 2017. the infra nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). they are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. before hospitalization and until the patient is discharged, the infra nurse transmits to the personnel involved all the information necessary for the proper continuation of care. in addition to legal and regulatory obligations, the infra nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy. the infra study is an observational study aimed at assessing the feasibility of the infra health circuit and evaluating the benefit for the patients and the healthcare staff.


Eligibility criteria:
inclusion criteria: * 13 years old or more * physical or mental disability, according to french law n°2005-102 of february 11th, 2005 * requiring an adaptation of the healthcare circuit * indication of a planned surgical procedure exclusion criteria: * outpatient * emergency surgery
the effects of synbiotics on morbidity and mortality in preterm infants

Conditions: Necrotizing Enterocolitis; Sepsis

Summary: study, the inclusion of very low birth weight premature infants followed in dr.sami ulus maternity and children training and research hospital, department of neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of nec and sepsis are planned. randomization and the number of patients planned to separate into groups.

patients separated into four groups using the sealed envelope method.

Eligibility criteria:
inclusion criteria: * vlbw infants admitted to nicu at the first 7 days of life exclusion criteria: * expected life lower than 7 days, * babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.), * severe asphyxia, * severe congenital anomaly

Keywords: necrotizing enterocolitis sepsis length of hospital stay mortality
the safety, efficacy and pharmacokinetics of arq-151 cream in subjects with chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a parallel group, double blind, vehicle-controlled study in which roflumilast (arq-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (qd) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.


Eligibility criteria:
inclusion criteria: * participants legally competent to sign and give informed consent * males and females ages 18 years and older (inclusive) * clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the investigator * females of childbearing potential (focbp) must have a negative urine pregnancy test at screening (visit 1) and baseline (visit 2). in addition, sexually active focbp must agree to use at least one form of highly effective contraception throughout the trial. * in good health as judged by the investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis. * subjects are considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: * planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed. * females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * previous treatment with roflumilast cream or its active ingredient * subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the investigator. * subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication. * subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation.
post-operative hyper-sensitivity assessment after immediate versus delayed dentine sealing in teeth for indirect tooth colored restorations

Conditions: Hypersensitivity Dentin

Summary: picot elements:p: teeth restored with indirect tooth colored restoration i: immediate dentin sealing using universal adhesive c: delayed dentin sealing o: post-operative hypersensitivity t: -hypersensitivity assessment one week during provisionalization period and post-cementation s: randomized controlled clinical trial


Eligibility criteria:
inclusion criteria: * extensive carious lesions indicated for indirect restorations * lower first molars * age of patients range is 18 -50 years * patients have not received antibiotic therapy for 1 month before sampling * males or females (both genders) * patients with good oral hygiene * co-operative patients approving the trial exclusion criteria: * pregnancy * systemic disease or severe medical * patients having complications as: periodontal problems mobile teeth, arrest caries and non-vital teeth * heavy smoking patients * xerostomia * lack of compliance
interplay between adherence to the mediterranean diet, lipid profile and blood pressure: a comparative survey among healthcare and non-healthcare female workers

Conditions: Diet Habit; Hypercholesterolemia; Hypertension

Summary: the study aims at testing the level of adherence to the mediterranean diet among health-workers, comparing this aspect to the extra-working physical activity, anthropometric measures and prevalence of cardiovascular, metabolic and neoplastic diseases previously diagnosed.

the study had a cross-sectional setting and included employees of both genders currently in service. baseline data collection was structured as follows: * clinical assessment and pathological history * anthropometric measurements; * haematochemical examinations; * screening to adherence to med-diet by using "meddietscore" questionnaire * assessment of the harvard cancer risk index for the evaluation of risk factors, modifiable and not, of the most frequent oncological diseases in italy (colon, lung, breast and prostate). the index provides an estimate of individual cancer risk and is not equivalent to a cancer diagnosis. in addition, the harvard cancer risk index itself can allow the doctor to advise the worker on useful measures to reduce it; * international physical activity questionnairre (ipaq) * major anthropometric and haematochemical data also allow to obtain one of the most used risk indexes for cardiovascular diseases in the scientific literature the framingham score.

Eligibility criteria:
inclusion criteria: * women of working age * level of education at least equal to bachelor's degree exclusion criteria: * men * women under 20 years old or over 65 years old

Keywords: mediterranean diet lipid profile healthcare workers
to yield further information on the efficacy and safety of viagra among subjects with arterial hypertension .

Conditions: Impotence; Hypertension

Summary: to assess changes with respect to erectile dysfunction in subjects treated with viagra and antihypertensive therapy.


Eligibility criteria:
inclusion criteria: * subjects with arterial hypertension treated with one or more antihypertensive agents, the doses of which have been stable for at least 4 weeks prior to the baseline visit, with a documented clinical diagnosis of ed and a confirmation of this by a qualification of 21 or less on the shi-m. exclusion criteria: * subjects with resting sitting systolic blood pressure \>170 or \ 90 or \<50mmhg, with significant cardiovascular disease and retinitis pigmentosa, treatment with nitrates, alfablockers or cyp3a4 inhibitors.
dynamics of drug resistance-associated mutations in hiv-1 dna reverse transcriptase clearance during effective antiretroviral therapy

Conditions: HIV-1-infection

Summary: in view of the prolongation of patients living with hiv's life expectancy, the question of optimization of art, which is still a life-long treatment, becomes central. while most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. the switch to dual regimen strategies represent one of the approaches for treatment optimization. circulating hiv-1 resistant variants can be archived in viral reservoirs, where they can persist for an unknown duration and reemerge in case of therapeutic selective pressure. there is a need to assess the dynamic of archived drug resistance associated mutations (drams) clearance in cell-associated hiv dna after a long period of virological control, in the perspective of arvs recycling. the investigators postulate that it could be interesting in the future to recycle arv drugs (that where classified as "resistant" in the past) in subsequent regimen. the question is particularly important for 3tc/ftc for subsequent new regimen and for the use of dual regimen (disappearance of m184v). thus, the investigators propose a retrospective, longitudinal analysis on blood-cell-associated hiv-1 dna samples in order to investigate by sanger and ultra deep sequencing the dynamics of decay and persistence of dna hiv-1 variants harboring key drug resistance-associated mutations to nrtis, in particular m184v, in patients with sustained virological control for at least 5 years under effective art.


Eligibility criteria:
inclusion criteria: * hiv-1 infected * age ≥ 18 years * genotypic resistance test performed at time of failure and harboring at least m184v * fully suppressed hiv viral load for at least 5 or 10 years. * triple therapy or 2 drug regimen during the entire follow-up * availability of at least 1 stored whole blood sample /year exclusion criteria: * no genotypic resistance test available at time of failure.
impact of paresthesia on postoperative neurological symptoms

Conditions: Interscalene Block; Postoperative Pain

Summary: in this study, the effect of paresthesia occurring during the interscalene block procedure on the incidence of postoperative neurological symptoms will be investigated. paresthesia is defined as an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." the status of postoperative neurological symptoms in patients at the end of the block's effective duration will be assessed through phone interviews, evaluating symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness.

our study includes patients aged 18-65 years with american society of anesthesiologists (asa) physical status i or ii who undergo interscalene nerve block prior to arthroscopic shoulder surgery under general anesthesia. all patients will be fasting according to standard protocol. during the preoperative period, patients' age, comorbidities, gender, body mass index (bmi), asa scores, and preoperative quality of recovery-15 (qor-15) scores will be recorded. in the operating room, possible complications related to the block (paresthesia, horner's syndrome, dyspnea, hoarseness) will be monitored in the preoperative area. during the intraoperative period, data such as pulse, blood pressure, infusion fluids, intraoperative remifentanil requirements, anesthesia duration, and surgical time will be recorded. in the postoperative period, postoperative pain status, block duration, postoperative nausea and vomiting, need for rescue analgesics and antiemetics, and qor-15 scores on the first day will be assessed in the recovery room and ward. additionally, postoperative neurological symptoms and qor-15 scores will be followed via telephone on the 3rd, 7th, 10th, and 30th days after discharge. for patients developing postoperative pain, pain intensity will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptoms and 10 represents maximum severity.

Eligibility criteria:
inclusion criteria: * asa physical status i to ii * age range of 18-65 years * patients planned for interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia exclusion criteria: * body mass index \>35 kg/m²) * history of drug use * patient's refusal to participate in the study * psychiatric disorders * central nervous system diseases * vestibular disorders * presence of diabetes, neuropathy, and paralysis * pregnancy * open shoulder surgery * allergy to local anesthetics * coagulopathy * severe thrombocytopenia * infection at the puncture site * pre-existing neuropathy in the limb to be operated on * use of opioid and antiemetic medications before surgery * use of dexamethasone * lung disease * low baseline oxygen saturation * patients who cannot cooperate in the postoperative period (e.g., mental retardation, delirium, language acquisition deficiency, etc.)

Keywords: interscalene block paresthesia postoperative neurological symptoms
hepatic artery infusional floxuridine to treat pancreatic cancer liver metastases

Conditions: Pancreatic Adenocarcinoma; Liver Metastases

Summary: this is a single arm, phase ii study without blinding. the purpose is to determine the impact of hepatic artery infusion floxuridine (fudr) on liver metastases from pancreatic adenocarcinoma. patients at spectrum health will receive standard of care chemotherapy. they will also receive chemotherapy via surgically placed hepatic artery infusion (hai) pump.

this study hypothesizes that the combination of floxuridine (fudr), a type of chemotherapy, delivered via a hepatic artery infusion (hai) pump, with standard of care systemic chemotherapy will lead to improved survival in the treatment of pancreatic cancer liver metastases. patients will receive 6 cycles of fudr and will be followed for two years.

Eligibility criteria:
inclusion criteria: * biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases * elevated cancer antigen 19-9 (ca19-9) at diagnosis (\>37 u/ml) * ages 18-75 years * karnofsky performance status ≥70 * ability to undergo general anesthesia and hai pump placement procedure * ct or mri scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment * received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging. exclusion criteria: * primary tumor resected * model for end stage liver disease (meld) score \>20, using the variables of: bilirubin, serum sodium, international normalized ratio (inr), serum creatinine, and dialysis twice in the past week. * greater than 60% liver parenchymal involvement by tumor * evidence of peritoneal metastases * current alcohol abuse * pregnant or lactating women

Keywords: pancreatic cancer, pancreatic ductal carcinoma, liver metastases, hai, hepatic artery infusion pump, fudr, floxuridine
predictors of bone mineral density in lupus nephritis activity

Conditions: Bone Mineral Density and Lupus Nephritis Activity

Summary: our aim in this study is correlation of histopathology of renal biopsy in sle with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis

systemic lupus erythematosus (sle) is an autoimmune disorder characterized by multisystem damage, leading to significant health issues \[1\]. there is growing concern over the adverse effects of medications used to treat sle and the potential long-term complications \[2\]. lupus nephritis (ln) is a severe and frequently manifestation of sle, associated with significant morbidity and mortality \[3-5\]. research indicates that female patients with sle are at a higher risk of developing reduced bone mineral density (bmd) \[6-9\]. moreover, women exhibit a high prevalence of osteoporosis and osteoporotic fractures \[10\]. osteoporosis is a common and serious complication of sle, contributing to increased morbidity and mortality rates \[11, 12\]. there is a notable gap in the literature regarding osteoporosis prevalence among ln patients. risk factors such as glucocorticoid therapy, early menopause, and low calcium and vitamin d intake are known to contribute to bone loss \[13-16\], yet the specific risk factors associated with osteoporosis in ln patients vary by country, indicating a need for further research in this area. the pathophysiology of bone mineral density (bmd) reduction in systemic lupus erythematosus (sle), particularly in relation to lupus nephritis (ln) activity, is multifactorial and complex. the mechanisms behind this association involve immune system dysregulation, chronic inflammation, steroid use, kidney dysfunction, and alterations in mineral metabolism (17)

Eligibility criteria:
inclusion criteria: the patients with lupus nephritis based on kdigo over 18 years and less than 60 years the patient diagnosed as sle with lupus nephritis and in active form. the patient diagnosed as sle with lupus nephritis and without active criteria the patient consent. exclusion criteria: patients with sle and also diagnosed as end stage renal disease on regular hemodialysis * association of another autoimmune as rheumatoid arthritis * association of hcv, hbv * association of diabetes mellitus or malignancy * patient had history of vitamin d supplementation
preoperative dual antiplatelet therapy: platelet function and influence of cardiopulmonary bypass

Conditions: Cardiopulmonary Bypass; Platelet Disorder; Bleeding Disorder; Platelet Dysfunction Due to Drugs

Summary: patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding. present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods. it is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.

taking antiplatelet medication before cardiac surgery increases the risk for bleeding. the surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern. the present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients. the platelet function will be tested before, during and after surgery by the use of two independent methods.

Eligibility criteria:
inclusion criteria: * patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery exclusion criteria: * abnormal coagulation verified from preoperative assessments, platelet count \<100 000, warfarin medication and renal insufficiency (gfr \< 60 ml/min)